Intravenous Tramadol CRL Casts Shadow On Avenue’s Cipla Deal
Avenue’s two-stage deal with an arm of Cipla faces uncertainty following a US Complete Response Letter for its intravenous tramadol. The US firm says it is "very surprised" with the potential safety concern raised and plans to seek a meeting with the agency at the earliest to resolve the issue.
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Keeping Track: Gavreto, Sogroya Bring Annual CDER Novel Approvals To 40; New Analgesic Products Make It Past US FDA
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Biocon Biologics upbeat on Lantus follow-on’s long revenue stream and prospects for interchangeability, while operational challenges resulted in some supply constraints during the fiscal second quarter.